• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » FLASH: House panel speeds FDA user fee bill

FLASH: House panel speeds FDA user fee bill

May 8, 2012 By MassDevice staff

MassDevice.com news

After a brisk, 30-minute hearing, a U.S. House panel cleared a bill re-authorizing the user fees medical device and pharmaceutical companies pay the FDA to have their products reviewed.

The House Energy & Commerce Committee’s health subcommittee cleared the measure on a voice vote at about 10:30 this morning, after adding an amendment from chairman Rep. Joe Pitts (R-Penn.) to address "technical changes to the committee draft recommended by the FDA and stakeholders," Pitts said during the hearing.

Sign up to get our free newsletters delivered straight to your inbox

A companion bill fairly flew through the Senate’s Health, Education, Labor & Pensions Committee in April. The House version must still be passed by the full Energy & Commerce panel before heading to the chamber’s floor. Democrats managed to deflect a Republican attempt to alter the watchdog agency’s mission statement to include promoting job growth, competition and economic growth were left by the wayside.

The Senate HELP Committee forwarded the bill with near unanimous support, adding some language to beef up the FDA’s safety regulations and allow the federal watchdog agency to conduct safety studies of devices after they’ve been approved and to grant conditional approvals contingent on further trials.

Several other bills were withdrawn ahead of the panel vote, including Sen. Jeff Merkley’s (D-Ore.) amendment to give the FDA "predicate nullification" authority – the ability to reject 510(k) applications based on recalled devices.

Lawmakers are further motivated to maintain bipartisan momentum on the bill before political grandstanding threatens to take over the conversation when the Supreme Court issues its ruling on President Barack Obama’s landmark health care reform law next month.

AdvaMed issued a statement late in April commending legislative efforts toward approval of the user fee acts, which have thus far avoided much of the bipartisan squabbling that often accompanies such items.

"Mark up is an important milestone in the reauthorization process, and we are encouraged by the bipartisan support this legislation has received," AdvaMed chairman & CEO Stephen Ubl said in a prepared statement. "We are hopeful it will remain on track to pass in a timely fashion."

The device advocate was an instrumental player in drafting the new user fee deal, and new AdvaMed chairman and Zimmer (NYSE:ZMH) president & CEO David Dvorak named passage of the latest user fee agreement as 1 of the top priorities of his 2-year term.

"There are very powerful and very well-financed interests here that would be extremely upset if this were to get bogged down," National Coalition on Healthcare president John Rother told Politico. "I think that the combined power of the industries regulated by the FDA would not be something anybody would want to tangle with when it comes to getting this legislation done. I just don’t see it happening."

The White House Office of Management & Budget in March month signed off on the Medical Device User Fee & Modernization Act, which doubles the user fees med-tech makers pay for agency reviews, from $295 million over 5 years to $595 million. In return, the FDA committed to meeting a series of performance goals.

The bill will head to the House Energy & Commerce Subcommittee tomorrow for an open markup session.

Filed Under: News Well Tagged With: MDUFMA, U.S. House of Representatives

More recent news

  • Tandem continues to deliver more options, benefits for those with diabetes
  • Breaking: Sequel to launch twiist automated insulin delivery system next month
  • Dexcom shares U.S. report on CGM benefits for type 2 diabetes
  • Data backs Medtronic MiniMed 780G for type 2, children as company seeks expanded indications
  • Endogenex data supports type 2 diabetes procedure

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy